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Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement

Key facts

Who runs it
VA Office of Research and Development
Where
Boston, Cincinnati, and Durham, United StatesSee the 3 sites
Trial code
Status
Recruiting
People taking part
200 people, planned
Started
1 Jul 2022
Expected to end
31 Mar 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Brief Family Intervention (BFI)
Record updated
20 March 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • a current DSM-5 diagnosis of PTSD
  • Veteran status
  • willing to have a family member involved in the study
  • has recently begun or is currently initiating individual CPT or PE (completed no more than 3 sessions of the protocol at the time of the baseline assessment); If taking psychotropic medication, the Veteran must be on a stable dose for at least 30 days
  • age 18 or older, family member of the Veteran (significant other, parent, adult child, sibling, etc.)
  • currently having frequent contact with the Veteran (three or more times per week)

Who cannot take part

  • current engagement in couple/family treatment with the identified family member participant
  • current severe substance use disorder (mild/moderate use disorders will not be excluded; any level of nicotine or caffeine use disorder accepted)
  • current psychosis or unstable bipolar disorder diagnosis
  • significant cognitive impairment
  • high suicidal risk
  • same as listed for Veterans. Additionally
  • family members will NOT be permitted to participate if they meet criteria for current PTSD

Where in United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, United StatesContact: Johanna Thompson-Hollands, PhDTaking people
  • Cincinnati VA Medical Center, Cincinnati, OHCincinnati, United StatesContact: Nicole Pukay-Martin, PhDTaking people
  • Durham VA Medical Center, Durham, NCDurham, United StatesContact: Nicole Pukay-Martin, PhDTaking people

About the trial

What the trial wants to find out

Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention.

Read full original descriptionShow less

Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.

The 2 groups in the trial

  • BFITreatment being tested

    Family members in this arm receive the 2-session BFI intervention.

    Treatment: Brief Family Intervention (BFI)

  • No BFINo study treatment, for comparison

    Family members in this arm do not receive the BFI sessions

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
20 March 2026